1. Time to disease flare was significantly shorter in the placebo group versus baricitinib.
2. There was no difference in serious adverse events between the baricitinib and placebo groups.
Evidence Rating Level: 1 (Excellent)
Study Rundown: Juvenile idiopathic arthritis (JIA) is defined by the onset of polyarticular joint pain before age 16 and can severely affect an individual’s quality of life. First-line treatment for JIA includes nonsteroidal anti-inflammatory drugs (NSAIDs) and biologic disease-modifying antirheumatic drugs (DMARDs), however, many patients with JIA continue to experience refractory symptoms. This randomized controlled trial aimed to assess the safety and efficacy of baricitinib, an oral Janus kinase 1/2-selective inhibitor, versus placebo, in patients with refractory JIA. The primary outcome of this study was time to disease flare in the withdrawal period, while key secondary outcomes included the proportion of patients with a flare and change in the Juvenile Arthritis Disease Activity Score 27 (JADAS-27). According to study results, baricitinib was effective in reducing JIA flare rates in patients without increasing rates of serious adverse events among patients with JIA refractory to standard therapy. Although this study was well done, it was limited by a small follow-up period, thus affecting the validity of the findings.
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In-depth [randomized-controlled trial]: Between Dec 17, 2018, and Mar 3, 2021, 263 patients were screened for eligibility across 75 centres in 20 countries. Included were patients aged 2 to <18 years with various forms of JIA (polyarticular, extended oligoarticular, enthesitis-related, and juvenile psoriatic arthritis) refractory to standard treatments. Altogether, 220 patients were included in the final analysis. The primary outcome of time to disease flare was significantly longer in the baricitinib group versus placebo (not evaluable in baricitinib due to <50% flare event vs. 27.14 weeks in placebo, hazard ratio [HR] 0.241, 95% confidence interval [CI] 0.128-0.453, p<0.0001). Serious adverse events were comparable in the baricitinib and placebo groups (5% vs. 4%, incidence rate [IR] 9.7 vs. 10.2 per 100 patient-years at risk) with pulmonary embolism (1%, IR 2.4) in the baricitinib group being most common. Overall, findings from this study suggest that baricitinib may be effective for the treatment of refractory JIA and possesses a tolerable safety profile.
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